TOL-463 is effective and safe in the treatment of bacterial vaginosis and vulvovaginal candidiasis, with the vaginal insert demonstrating a more efficacious profile for both conditions overall.

TOL-463, a boric acid-based treatment that is enhanced with ethylenediaminetetra-acetic acid (EDTA), is effective and safe in treating bacterial vaginosis and vulvovaginal candidiasis, according to a study published in Clinical Infectious Diseases.

This single-blind, randomized, phase 2 study included 106 individuals, 53 of whom had bacterial vaginosis, 36 of who had vulvovaginal candidiasis, and 17 of whom had both. Researchers randomly assigned participants in a 1:1 ratio to 1 week of either TOL-463 vaginal insert or the same medication in a gel formulation. Bacterial vaginosis was cured in 59% (95% CI, 41%-75%) of participants using TOL-463 insert and in 50% (95% CI, 31%-69%) of those using the gel. In patients with vulvovaginal candidiasis, the cure rate with the TOL-463 insert was 92% (95% CI, 67%-99%) vs 81% (95% CI, 57%-93%) for patients who received treatment with the gel. The most common adverse event was a sensation of vulvovaginal burning, which occurred in 9.6% of users. Otherwise, both gel and insert formulations of the medication were well tolerated and led to no secondary vulvovaginal candidiasis.

Among the participants in this study, the mean age was 31, and 69% were African American. Test of cure was administered between days 9 and 12, with safety assessments occurring both at test of cure and between days 21 and 30.

The study researchers concluded that “TOL-463 is effective and safe in the treatment of [bacterial vaginosis] and [vulvovaginal candidiasis], with the vaginal insert demonstrating a more efficacious profile for both conditions overall. The potential dual indication of TOL-463 likely represents a benefit in the management of infectious vaginitis as diagnosis of these infections is often imprecise. Phase 3 trials will further define the role of TOL-463 in a more representative gynecology population across a broader range of practice settings and patient types.”